Azelix understands the importance of proper planning of your product. Based on our experience and seasoned team of regulatory and scientific strategy team, we are able to provide a map taking you from wherever your starting may be such as pre-clinical phase to your goal = NDA or licensing/early exist. Throughout our consultation, we will always provide you options and recommendation of the best possible approach with honesty and transparency. Our team will provide you services such as:

  • Product Development Strategy
  • Study Design & Scientific Advice
  • Submission Strategy
  • Meeting Participation: pre-IND, EOP1, EOP2
  • Application Preparation & Submission
  • IND, NDA, BLA, 505(b)(2), ANDA
  • eCTD Compliance
  • Designated US Agent